Boosting Catheter and Related Systems and Methods

ABSTRACT

The various embodiments herein relate to a boosting catheter for positioning through a conventional guiding catheter into the vasculature of a patient, the boosting catheter having a distal tubular member and a proximal elongated shaft coupled to the distal tubular member.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority as a continuation-in-part applicationto U.S. application Ser. No. 14/864,296, filed Sep. 24, 2015 andentitled “Boosting Catheter and Related Systems and Methods,” whichclaims priority as a continuation application to U.S. application Ser.No. 14/210,572, which is now U.S. Pat. 9,144,662, which issued Sep. 29,2015 and is entitled “Boosting Catheter and Related Systems andMethods,” which claims priority to U.S. Provisional Application No.61/793,982, filed Mar. 15, 2013 and entitled “Extension Guide Catheter,”all of which are hereby incorporated herein by reference in theirentireties.

FIELD OF THE INVENTION

The various embodiments disclosed herein relate to guiding catheters foruse as medical devices, and more particularly to boosting catheters foruse with guiding catheter systems.

BACKGROUND OF THE INVENTION

The general use of catheters as medical devices is very well-developedby now. U.S. Pat. No. 4,581,017 to Sahota, for example, shows the use ofa guide catheter for insertion into an artery to assist with treatingthe artery (e.g. with a stenosis); and it further shows the use ofanother catheter for telescoping insertion into the first catheter toextend beyond the first catheter to treat or access portions of theartery that the first catheter cannot reach because of its largerdiameter or lack of flexibility, trackability or support. Subsequentpatents show further developments of such telescoping or extensioncatheter systems. For example, U.S. Pat. No. 5,385,562 to Adams et al.,U.S. Pat. No. 5,439,445 to Kontos, and U.S. Pat. No. 5,290,247 toCrittendon all show the use of a catheter having a tubular portion thatextends or telescopes beyond the guiding catheter, and an elongatedmanipulation/insertion wire or shaft attached to the tubular portion tomanipulate the tubular portion axially—in push/pull fashion—within theguiding catheter after it has been inserted through the hemostasis valveand into the guiding catheter. The Adams '562 patent suggests that theproximal manipulation/insertion wire may actually be a low-diametertubular shaft for conducting air to inflate and deflate a restrictionballoon that restricts movement of the tubular portion.

According to conventional practice with these types of devices, doctorsor technicians often introduce a contrast solution, flushing agent, ortherapeutic agent into and through the guiding catheter in order toassist in the viewing of arteries, veins, and other tissues in the body(e.g. by x-ray or flouroscopy) or for other procedural or therapeuticreasons. In some cases, though, it is desirable to limit the use of suchsolutions because too much of the solution can harm the patient.Introducing the solution through the guiding catheter may result ineither too much solution entering the body or the solution not beinginjected at the correct target location. The diameter of the guidingcatheter must be large enough to conduct a variety of tools and devicesduring the procedure, and so it is not practical to decrease thediameter of the guiding catheter in order to limit the usage of contrastsolution.

Accordingly, there has been a need in the art for improved boostingcatheters and related methods and system.

SUMMARY OF THE INVENTION

Discussed herein are various boosting catheter embodiments for use withstandard guiding catheter.

In Example 1, a catheter comprises a distal tube and a proximal shaftoperably coupled to a proximal portion of the distal tube. The distaltube comprises a tubular wall, a tube lumen defined within the tube bythe tubular wall, and a proximal opening in fluid communication with thetube lumen, wherein the proximal opening is configured to allow amedical device to be positioned therethrough. The proximal shaftcomprises a first shaft lumen defined in the proximal shaft, a secondshaft lumen defined in the proximal shaft, a first elongate memberdisposed within the first shaft lumen, and a second elongate memberdisposed within the second shaft lumen. The proximal shaft is configuredto extend distally into a portion of the distal tube such that the shaftlumen extends distally past a proximal end of the distal tube.

Example 2 relates to the catheter according to Example 1, wherein thefirst elongate member is configured to extend distally into a firstportion of the tubular wall, and the second elongate member isconfigured to extend distally into a second portion of the tubular wall.

Example 3 relates to the catheter according to Example 1, wherein theproximal shaft further comprises a first distal opening in fluidcommunication with the first shaft lumen and a second distal opening influid communication with the second shaft lumen, whereby the first andsecond shaft lumens are in fluid communication with the tube lumen.

Example 4 relates to the catheter according to Example 3, wherein atleast one of the first shaft lumen is configured to receive fluid suchthat fluid can be caused to flow distally in a space defined between aninner wall of the first shaft lumen and the first elongate member andout of the first distal opening, and the second shaft lumen isconfigured to receive fluid such that fluid can be caused to flowdistally in a space defined between an inner wall of the second shaftlumen and the second elongate member and out of the second distalopening.

Example 5 relates to the catheter according to Example 3, wherein theproximal shaft is configured to extend distally into a portion of thetubular wall such that the first and second shaft lumens extend distallyinto the tubular wall and such that the first and second distal openingsare in fluid communication with the tube lumen.

Example 6 relates to the catheter according to Example 1, wherein thefirst elongate member is fixedly disposed within the first shaft lumen,such that the first elongate member is not slidable in relation to thefirst shaft lumen, and the second elongate member is fixedly disposedwithin the second shaft lumen, such that the second elongate member isnot slidable in relation to the second shaft lumen.

Example 7 relates to the catheter according to Example 1, wherein thefirst elongate member is slidably disposed within the first shaft lumensuch that the first elongate member is slidable in relation to the firstshaft lumen, and the second elongate member is slidably disposed withinthe second shaft lumen such that the second elongate member is slidablein relation to the second shaft lumen.

Example 8 relates to the catheter according to Example 1, wherein atleast one of the first and second elongate members defines a lumentherein.

Example 9 relates to the catheter according to Example 1, wherein thefirst and second elongate members have no lumen.

Example 10 relates to the catheter according to Example 1, wherein theproximal shaft further comprises a third shaft lumen defined in theproximal shaft and a third distal opening in fluid communication withthe third shaft lumen, whereby the third shaft lumen is in fluidcommunication with the tube lumen.

Example 11 relates to the catheter according to Example 10, wherein thethird shaft lumen is configured to receive fluid such that fluid can becaused to flow distally along the third shaft lumen and out of the thirddistal opening.

Example 12 relates to the catheter according to Example 10, wherein theproximal shaft further comprises at least a fourth shaft lumen definedin the proximal shaft and at least a fourth distal opening in fluidcommunication with the at least the fourth shaft lumen, whereby the atleast the fourth shaft lumen is in fluid communication with the tubelumen.

In Example 13, a method of using a boosting catheter in combination witha standard guiding catheter to perform a procedure at a predeterminedlocation within the vasculature of a patient comprises positioning thestandard guiding catheter into a target vessel in the patient, insertingthe boosting catheter into the standard guiding catheter, urging theboosting catheter distally through the standard guiding catheter suchthat a distal portion of the distal tube extends distally out of thedistal end of the standard guiding catheter, and performing a procedurethrough the boosting catheter and standard guiding catheter. Theboosting catheter comprises a distal tube comprising a tubular wall anda tube lumen defined within the tube by the tubular wall, and a proximalshaft operably coupled to a proximal portion of the distal tube. Theproximal shaft comprises first and second shaft lumens defined in theproximal shaft, and first and second elongate members disposed in thefirst and second shaft lumens, respectively, wherein each of the firstand second elongate members is configured to extend distally into aportion of the tube lumen.

Example 14 relates to the method according to Example 13, wherein theproximal shaft further comprises a first distal opening in fluidcommunication with the first shaft lumen, whereby the first shaft lumenis in fluid communication with the tube lumen, and a second distalopening in fluid communication with the second shaft lumen, whereby thesecond shaft lumen is in fluid communication with the tube lumen.

Example 15 relates to the method according to Example 14, wherein theperforming the procedure further comprises introducing the fluid into atleast one of the first and second shaft lumens at the proximal end ofthe proximal shaft, and conducting the fluid distally along the lengthof the at least one of the first and second shaft lumens and out of atleast one of the first and second distal openings.

Example 16 relates to the method according to Example 13, wherein theperforming the procedure further comprises positioning a medical deviceat the predetermined location through the boosting catheter and guidingcatheter, and performing an interventional, diagnostic, or therapeuticprocedure using the medical device.

Example 17 relates to the method according to Example 13, wherein theproximal shaft further comprises a third shaft lumen defined in theproximal shaft and a third distal opening in fluid communication withthe third shaft lumen, whereby the third shaft lumen is in fluidcommunication with the tube lumen.

Example 18 relates to the method according to Example 17, wherein theperforming the procedure further comprises introducing a fluid into thethird shaft lumen at a proximal end of the proximal shaft, andconducting the fluid distally along the length of the third shaft lumenand out of the third distal opening.

Example 19 relates to the method according to Example 18, wherein theconducting the fluid out of the third distal opening further comprisesconducting the fluid out of the third distal opening into the lumen ofthe distal tube.

Example 20 relates to the method according to Example 18, wherein theconducting the fluid out of the third distal opening further comprisesdispersing the fluid out of the third distal opening to an area externalto the distal tube.

Example 21 relates to the method according to Example 17, wherein theproximal shaft further comprises at least a fourth shaft lumen definedin the proximal shaft and at least a fourth distal opening in fluidcommunication with the at least the fourth shaft lumen, whereby the atleast the fourth shaft lumen is in fluid communication with the tubelumen.

Example 22 relates to the method according to Example 13, wherein thefirst elongate member is fixedly disposed within the first shaft lumen,such that the first elongate member is not slidable in relation to thefirst shaft lumen, and the second elongate member is fixedly disposedwithin the second shaft lumen, such that the second elongate member isnot slidable in relation to the second shaft lumen.

Example 23 relates to the method according to Example 13, wherein thefirst elongate member is slidably disposed within the first shaft lumensuch that the first elongate member is slidable in relation to the firstshaft lumen, and the second elongate member is slidably disposed withinthe second shaft lumen such that the second elongate member is slidablein relation to the second shaft lumen.

In Example 24, a method of using a boosting catheter in combination witha standard guiding catheter to perform a procedure at a predeterminedlocation within the vasculature of a patient comprises positioning thestandard guiding catheter into a target vessel in the patient, insertingthe boosting catheter into the standard guiding catheter, urging theboosting catheter distally through the standard guiding catheter suchthat a distal portion of the distal tube extends distally out of thedistal end of the standard guiding catheter, and performing a procedureusing the medical device. The boosting catheter comprises a distal tubeand a proximal shaft operably coupled to a proximal portion of thedistal tube. The distal tube comprises a tubular wall, a tube lumendefined within the tube by the tubular wall, and a proximal opening influid communication with the tube lumen, wherein the proximal opening issized to allow a medical device to be positioned therethrough. Theproximal shaft comprises first and second shaft lumens defined in theproximal shaft, a first elongate member disposed within the first shaftlumen, the first elongate member configured to extend distally into afirst portion of the tubular wall, and a second elongate member disposedwithin the second shaft lumen, the second elongate member configured toextend distally into a second portion of the tubular wall.

Example 25 relates to the method according to Example 24, wherein theproximal shaft further comprises first and second distal openings influid communication with the first and second shaft lumens,respectively. Further, the performing the procedure further comprisesintroducing a fluid into the first and second shaft lumens at a proximalend of the proximal shaft, and conducting the fluid distally along thelength of the first and second shaft lumens and out of the distalopening.

Example 26 relates to the method according to Example 25, wherein thefirst and second shaft lumens are in fluid communication with the tubelumen, wherein the conducting the fluid out of the first and seconddistal openings further comprises conducting the fluid out of the firstand second distal openings into the tube lumen of the distal tube.

Example 27 relates to the method according to Example 25, wherein thefirst and second shaft lumens are in fluid communication with an areaexternal to the distal tube, wherein the conducting the fluid out of thefirst and second distal openings further comprises conducting the fluidout of the first and second distal openings into the area external tothe distal tube.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

DESCRIPTION OF DRAWINGS

FIG. 1 is an environmental view showing the use of one embodiment of thesubject device in a conventional guiding catheter or sheath, which isused to perform various medical procedures.

FIG. 2A is a closer environmental view showing the distal end of aboosting catheter extending out the end of a conventional guidingcatheter engaged in the coronary vasculature, according to oneembodiment.

FIG. 2B is another environment view showing a boosting catheter in aguiding catheter and including a proximal portion and a distal portion,according to one embodiment.

FIG. 3A is a side view in partial section of a boosting catheter withtwo marker bands, according to one embodiment.

FIG. 3B is a side view in partial section of a boosting catheter withthree marker bands, according to another embodiment.

FIG. 3C is a side view in partial section of a boosting catheter withthree marker bands, according to a further embodiment.

FIG. 4A is a cross-sectional side view showing the proximal shaft of aboosting catheter, according to one embodiment.

FIG. 4B is an end view showing the proximal shaft of FIG. 4A.

FIG. 4C is a top view showing the proximal shaft of FIG. 4A.

FIG. 5 is a cross-sectional side view of the proximal shaft of aboosting catheter, according to another embodiment.

FIG. 6 is a cross-sectional side view of the proximal shaft of aboosting catheter, according to a further embodiment.

FIG. 7A is a top view of a boosting catheter showing the junction of theproximal and distal portions, according to one embodiment.

FIG. 7B is a cross-sectional side view of the boosting catheter of FIG.7A.

FIG. 7C is a cross-sectional end view of the proximal shaft of theboosting catheter of FIG. 7A.

FIG. 8A is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to oneembodiment.

FIG. 8B is a is a perspective view of a portion of the junction of theproximal and distal portions of the boosting catheter of FIG. 8A.

FIG. 9 is a cross-sectional side view of a boosting catheter showing thejunction of the proximal and distal portions, according to anotherembodiment.

FIG. 10 is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to a furtherembodiment.

FIG. 11 is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to yetanother embodiment.

FIG. 12 is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to anotherimplementation.

FIG. 13 is a cross-sectional top view of a proximal shaft of a boostingcatheter, according to one embodiment.

FIG. 14 is a cross-sectional top view of a proximal shaft of a boostingcatheter, according to another embodiment.

FIG. 15A is a cross-sectional view of a proximal shaft of a boostingcatheter, according to a further embodiment.

FIG. 15B is a cross-sectional view of another proximal shaft of aboosting catheter, according to yet another embodiment.

FIG. 16A is a cross-sectional view of a proximal shaft of a boostingcatheter, according to one implementation.

FIG. 16B is a cross-sectional view of a proximal shaft of a boostingcatheter, according to another implementation.

FIG. 16C is a cross-sectional view of a proximal shaft of a boostingcatheter, according to a further implementation.

FIG. 16D is a cross-sectional view of a proximal shaft of a boostingcatheter, according to yet another implementation.

FIG. 16E is a cross-sectional view of a proximal shaft of a boostingcatheter, according to another embodiment.

FIG. 16F is a cross-sectional view of a proximal shaft of a boostingcatheter, according to a further embodiment.

FIG. 16G is a cross-sectional view of a proximal shaft of a boostingcatheter, according to yet another embodiment.

FIG. 16H is a cross-sectional view of a proximal shaft of a boostingcatheter, according to another implementation.

FIG. 161 is a cross-sectional view of a proximal shaft of a boostingcatheter, according to a further implementation.

FIG. 17A is a cross-sectional side view of a proximal shaft of aboosting catheter, according to one embodiment.

FIG. 17B is a cross-sectional side view of a proximal shaft of anotherboosting catheter, according to a further embodiment.

FIG. 18A is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to oneimplementation.

FIG. 18B is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to anotherimplementation.

FIG. 18C is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to a furtherimplementation.

FIG. 19A is a cross-sectional side view of a proximal shaft of aboosting catheter, according to one embodiment.

FIG. 19A′ is an end view of the proximal shaft of the boosting catheterof FIG. 19A.

FIG. 19B is a cross-sectional side view of a proximal shaft of aboosting catheter, according to another embodiment.

FIG. 19C is a cross-sectional side view of a proximal shaft of aboosting catheter, according to a further embodiment.

FIG. 19D is a cross-sectional side view of a proximal shaft of aboosting catheter, according to yet another embodiment.

FIG. 19D′ is a side view of the proximal shaft of the boosting catheterof FIG. 19D, according to one embodiment.

FIG. 19D″ is a side view of the proximal shaft of the boosting catheterof FIG. 19D, according to another embodiment.

FIG. 20A is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to oneimplementation.

FIG. 20B is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to anotherimplementation.

FIG. 20C is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to a furtherimplementation.

FIG. 20D is a perspective view of a boosting catheter showing thejunction of the proximal and distal portions, according to anotherembodiment.

FIG. 21A is a cross-sectional side view of a boosting catheter showingthe junction of the proximal and distal portions, according to oneimplementation.

FIG. 21B is a cross-sectional top view of the boosting catheter of FIG.21A.

FIG. 22A is a perspective view of the side of a boosting cathetershowing the junction of the proximal and distal portions, according toone implementation.

FIG. 22B is a perspective view of the top of the boosting catheter ofFIG. 22A.

FIG. 22C is a perspective view of the underside of the boosting catheterof FIG. 22A.

FIG. 23 is a perspective view of the proximal shaft of a boostingcatheter, according to another embodiment.

FIG. 24 is a perspective view of the proximal shaft of a boostingcatheter, according to a further embodiment.

DETAILED DESCRIPTION

The various embodiments disclosed and contemplated herein relate to aboosting catheter that is adapted to be positioned through and extenddistally from a conventional guiding catheter, wherein the guidingcatheter is adapted to extend into a patient.

The various boosting catheter embodiments disclosed herein have a distaltubular portion adapted to extend through and beyond the distal end ofthe guiding catheter. The embodiments also include a proximal elongatedshaft connected to the tubular portion at a junction. In certainimplementations, the elongated shaft defines a lumen therein (that is,the shaft is hollow or has a hollow-body construction that defines alumen) or two or more lumens. The lumen(s) can be configured to conductfluid along the shaft towards or through the tubular portion or simplyto enhance the flexibility, trackability, and/or passage performance.According to some embodiments, the shaft defines at least one openingdisposed within or in fluid communication with the lumen of the distaltube such that fluid leaving the opening can flow through the tube.

In addition to serving as a conduit for fluids in certainimplementations, a manipulation shaft with at least one lumen can haveenhanced flexibility both in the axial direction and the longitudinal(or circumferential) direction. This configuration can further enhancethe advancement characteristics of the catheter as well as passage ofother devices through the guiding catheter (and alongside themanipulation shaft). In addition, the manipulation shaft with the atleast one lumen can exhibit a greater propensity to conform to the innerdiameter of the guiding catheter, thereby allowing more flexibility andallow enhanced passage of devices within the guiding catheter in thezones occupied by the manipulation shaft.

FIG. 1 depicts a conventional guiding catheter 12 being used in thegeneral operating environment, which is partially within a human body,and usually within an artery or vein. As shown in the figure, theguiding catheter 12 may be inserted into the vasculature through anumber of different access points in the body. For example, a femoralartery approach is shown at A, while a radial artery approach is shownat B. Further, other parts of the vasculature may be accessed withvarious guiding catheters or sheaths. For example, at C, a sheath isshown inserted through the femoral artery for a contralateral approachfor procedures in the leg or other parts of the body. In anotherexample, the sheath is inserted through the femoral artery to access therenal arteries in one of the kidneys at D. Regardless of the accesspoint or the target portion of the vasculature, the various boostingcatheter implementations disclosed herein can be used in combinationwith guiding catheters or sheaths to assist with various procedures. Forexample, the boosting catheter embodiments in combination with guidingcatheters or sheaths can be used to assist with the passage of otherinterventional, diagnostic, or therapeutic devices to various locationsin the vasculature. In other instances, the various implementations canbe used in combination with guiding catheters or sheaths to assist withthe transmission of contrast, diagnostic, or therapeutic fluids/agentsby injecting the fluids/agents through the boosting catheter to variouslocations, or by transmitting the fluids/agents through the guidingcatheter via a hemostasis valve and subsequently passing it through thedistal tube of the boosting catheter. In another example, the boostingcatheter embodiments in combination with guiding catheters or sheathscan be used to assist with the removal of thrombus, emboli, or debrispresent in the vasculature through the guiding catheter/sheath byapplying a vacuum at the proximal end of the guiding catheter/sheath.

As shown in FIG. 2A, various embodiments of a boosting catheter(generally shown at 10) as disclosed and contemplated here can be usedin conjunction with any conventional guiding catheter 12 for purposes ofthe various procedures described above. As shown in FIG. 2A, the distalend of the boosting catheter 10 is positioned through and extendeddistally from the distal end of the conventional guiding catheter 12.

Certain examples of boosting catheters 10 according to variousembodiments are shown in further detail in FIGS. 2B, 3A, 3B, and 3C.Each boosting catheter implementation 10 has two basic parts: a distalportion that is a comparatively large diameter tube (generally indicatedat 14) defining a lumen 36; and a proximal portion that is acomparatively smaller diameter elongate member such as a tube or rod,also referred to herein as a “manipulation shaft” (generally indicatedat 16). In certain embodiments, as best shown in FIGS. 3A-3C, themanipulation shaft defines at least one lumen 38 along the length of theshaft 16. Alternatively, the proximal portion 16 is a solid wire or railthat is not hollow. The one or more lumens 38 defined within themanipulation shaft 16 can extend to the proximal portion of the tubularshaft 14. The lumen(s) 38 can also extend through or alongside the lumen36 of the tubular shaft 14 and exit at the very distal end of the shaft14 or somewhere in between. The lumen(s) 38 may also extend beyond thetubular shaft 14. According to certain embodiments as will be describedin further detail below, the one or more lumens 38 are configured toreceive a fluid (such as, for example, a contrast solution) such thatthe fluid can be urged from the proximal end of the lumen 38 to thedistal end of the lumen 38 and thereby dispense or deliver the fluid outof the distal end of the shaft 16.

The larger diameter tube 14 is, according to one embodiment, madegenerally from flexible polymeric materials. The tube 14 can have, inone specific example, a PEBAX, polyurethane, or NYLON outer layer, and aPTFE inner layer. The tube 14 may also incorporate re-inforcing coil ormesh. The tube 14 may also incorporate radiopaque markers (such asmarkers 24, 26, or 28 as discussed below) on the tube 14. Themanipulation shaft 16 may also incorporate one or more visual markers,including radiopaque markers.

As shown in FIGS. 3A, 3B, and 3C, certain embodiments of the largerdiameter tube 14 can have three segments or more of differingflexibilities: low flexibility at the proximal end 18 of the tube 14,medium flexibility in the middle 20 of the tube 14, and high flexibilityat the distal end 22. More segments of varying flexibilities can also beused. In fact, the transition zone 40 (the area of overlap in which themanipulation shaft 16 is coupled to the larger tube 14) has varyingflexibility in that zone 40. The differing flexibilities can beaccomplished through combinations of differing materials,configurations, or geometries—as is known in the art (e.g. mesh or coilreinforcing, different PEBAX varieties, etc.). Moreover, differentlengths can be selected for the segments 18, 20, 22 and the transitionzone 40 according to design considerations. For example, if the smallerdiameter shaft 16 has at least one lumen 38, then the low flexibilitysegment 18 may be longer to obtain optimal advancement characteristics.This permits more flexibility along a greater length of the boostingcatheter 10 as needed to deal with anticipated curvature in the path thecatheter 10 must follow. An example of this is illustrated in FIG. 2B,which shows the smaller diameter tube 16 terminating where anticipatedcurves begin.

As mentioned above, the flexible tube 14 can have radiopaque markers.embedded in the tube 14 and placed along the length of the tube 14 forvarious purposes. For example, marker 24 can be used at or near thedistal tip 42 of the tube 14 to help the doctor locate the position ofthe tip 42. Another marker 26 could be used at or near the proximal end44 of the tube 14 to assist the doctor in locating that end 44 of thetube 14 relative to the end of the guiding catheter or to assist invisualizing the location of the proximal opening of the tube 14. In oneembodiment, the marker band 26 can be located near the proximal end 44of the tube but at a position on the tube 14 that is distal to the end44, as shown in FIGS. 3A-3C.

Further, in certain embodiments, a radiopaque marker (not shown) can belocated anywhere in or near the transition zone 40 (e.g. on themanipulation shaft 16 in or near the transition zone 40 or in the distaltube 14 in the transition zone 40). Further, any of the markers 24, 26,28 can be non-cylindrical. For example, one or more of the markers 24,26, 28 can be strips or other known configurations.

One or more of these markers 24, 26, 28 can be helpful to indicate tothe doctor or surgeon the location of the proximal end 44 of the tube 14in relation to the guiding catheter (such as catheter 12) so that theydo not insert or push the proximal end 44 past the distal end of theguiding catheter 12. In this regard, certain embodiments include a thirdmarker 28 located at some optimal point along the tube 14 in between theother two markers 24 and 26, as shown in FIGS. 2B, 3B, and 3C. As shownbest in FIG. 2B, the doctor or surgeon can use this third marker 28 totrack how far the tube 14 is extending beyond the guiding catheter 12.That is, the third marker 28 can be used in certain circumstances as alimit indicator. For example, in a specific embodiment having a tube 14that is 35 cm in length, the third marker band 28 may be located 15 cmfrom the distal end 42 of the tube 14 in order to indicate thispredetermined distance to the doctor, such that the doctor knows thedistance that the distal end 42 extends beyond the guide catheter 12.Depending on the specific configuration of the boosting catheter 10, thethird marker band 28 can be disposed in the low flexibility segment 18,the middle flexibility segment 20, or possibly even in the highflexibility segment 22.

It is understood that the distal tube 14 can have one, two, three, ormore markers as described above. It is further understood that anymarker arrangement of one or more markers, including the three markerarrangement, can be used in connection with a variety of boostingcatheter configurations, including those having a solid rail (e.g. aflat or round wire) or a hollow rail or proximal section with a lumen,such as a tube. In other implementations, one or more markers can bepositioned on the shaft 16.

In one implementation, the proximal portion 16 is an elongate member 16(such as a tube) having at least one lumen defined therein, wherein theelongate member 16 is made of at least one metal and/or at least onepolymer. One example of a metal that can be used is stainless steel,such as 304 or 316 grade stainless steel. According to certainembodiments, the tube 16 can be coated (for additional lubricity, forexample) with one or more materials such as TEFLON or PTFE, or withanother hydrophilic coating, or a hydrophobic coating (like silicone).The tube can also be made from nitinol (nickel-titanium) for improvedkink resistance.

In certain embodiments, the manipulation shaft 16 is coupled to thedistal tube 14 such that the shaft 16 and the one or more lumens 38defined in the shaft 16 extend into or through the distal tube 14.Various shaft 16 configurations can be used for this purpose. Forexample, FIGS. 4A-4C depict a distal portion of a manipulation shaft 16having a full diameter section 46 and a reduced diameter section 48 atthe distal end of the shaft 16. FIG. 4A depicts a side view of the shaft16, while FIG. 4B shows a front view of shaft 16 and FIG. 4C provides atop view of the shaft 16. As best shown in FIGS. 4B and 4C, the reduceddiameter section 48 has a substantially ovular cross-section, while thefull diameter section 46 has a substantially circular cross-section. Asbest shown in FIG. 4A, the lumen 38 of the shaft 16 extends through boththe full diameter 46 and reduced diameter 48 sections.

Certain embodiments, including the embodiment shown at FIGS. 4A-4C, areconfigured to be capable of dispersing fluids through the shaft 16,including fluids such as contrast solution, saline solution, ortherapeutic solutions. For example, the shaft 16 in FIGS. 4A-4C has alumen 38 and a distal opening 50 configured to allow for fluids to passthrough the lumen 38 and be dispersed out of the opening 50. Further,the reduced diameter section 48 with the lumen 38 is configured to becoupled to the distal tube 14 such that a distal portion of the reduceddiameter section 48 is integrated into a proximal portion of the tube 14in the transition zone (such as transition zone 40) as discussed infurther detail below. Alternatively, the reduced diameter section 48with the lumen 38 need not be used to transfer or disperse fluids andinstead can simply be configured to be coupled to the distal tube 14 asdisclosed herein. In such embodiments as will be described in furtherdetail below, each of the one or more lumens 38 is configured to have adistal opening (such as distal opening 50 discussed above) that placeseach of the lumens 38 in fluid communication with either the lumen 36 ofthe distal tube 14 or an exterior area of the distal tube 14.Alternatively, the manipulation shaft 16 can be configured to have nodistal opening and thus have one or more lumens that are not in fluidcommunication with the distal tube 14 or anything else at its distalend.

There can be benefits of a proximal portion having at least one lumen.As discussed above, it allows for transmission of fluid through at leastone conduit that is smaller in diameter than the guiding catheter. Incertain embodiments, the at least one lumen is sized specifically toconduct the desired amount of a specific fluid into the distal tube,into a wall of the distal tube, out of the wall of the distal tubethrough an opening somewhere along the length of the tube, or out of thedistal end of the distal tube. The control of the lumen size can allowfor transmission of more or less fluid, depending on what is desired.For example, less fluid can be desirable when the fluid is contrastsolution that is typically used in several catheter-based procedures,because greater amounts of contrast solution can cause harm to thepatient.

Additional exemplary configurations of the distal end of themanipulation shaft 16 are shown in FIGS. 5 and 6. In the embodimentshown in FIG. 5, the transition section 52 between the full diametersection 46 and the reduced diameter section 48 involves a narrowingaround the full circumference of the shaft 16 as shown (in contrast to anarrowing of one portion of the shaft 16 as shown in FIG. 4A).Alternatively, FIG. 6 depicts a shaft 16 having an extended taperedsection 47 from the full diameter section 46 to the reduced diametersection 48.

The various manipulation shaft 16 embodiments as discussed in furtherdetail elsewhere herein provide for a gradual change in flexibility fromthe proximal end of the shaft 16 to the distal end. Further, certainshaft implementations are configured such that the distal portion of theshaft 16 couples with the tube 14 in such a way as to maximize the innerdiameter (the lumen 36) of the tube 14. That is, in certainimplementations, the various boosting catheters 10 disclosed orcontemplated herein require a sufficiently accessible opening 44 (asbest shown in FIGS. 3A-3C) at the proximal end of the distal tube 14 toallow for the lumen 36 to be accessible for medical devices. In otherwords, the opening 44 must be large enough and/or have sufficientclearance to allow for easy insertion of various medical devices intothe opening 44 such that the devices can be urged distally through thetube 14 and out of the opening at the distal end 42 of the tube 14. Incertain of these embodiments, clearance at the opening at the proximalend 44 of the distal tube 14 can be optimized by minimizing the profile(by reducing the diameter, etc.) of the manipulation shaft 16 accordingto various configurations as disclosed herein.

As mentioned above, in accordance with some embodiments, the distalportion of the manipulation shaft 16 is integrated or embedded in theproximal end of the distal tube 14. For example, in certainimplementations, the distal tube 14 is molded over the distal end of themanipulation shaft 16, thereby creating a transition zone such as thezone 40 discussed above.

In certain embodiments, the distal end of the manipulation shaft 16 maybe coupled to the distal tube 14 in an eccentric manner, rather than aconcentric manner. That is, the shaft 16 is joined to the distal tube 14at one point or in one zone of the periphery or circumference of thedistal tube 14 (“eccentrically”), rather than being joined togetheraround the entire circumference of the shaft 16 and tube 14. Forexample, in one implementation as shown in FIGS. 7A-7C, the manipulationshaft 16 is coupled to the distal tube 14 at a point or area of the wall56 of the tube 14. The shaft 16 in this embodiment is made up of tworods 54A, 54B positioned within the lumen 38 of the shaft 16, as bestshown in FIG. 7C. Alternatively, the two rods 54A, 54B can be positionedin separate lumens, as best shown in the embodiment depicted in FIG. 23.In one embodiment, the rods 54A, 54B are solid (that is, they do nothave lumens). Alternatively, the rods 54A, 54B can be hypotubes 54A,54B, with each having a lumen defined therein. As best shown in FIGS. 7Aand 7B, a distal portion of the shaft 16 is coupled to and integral withan outer wall 56 of the distal tube 14 at the transition zone 40.Further, as best shown in FIG. 7A, the two rods 54A, 54B extend from thedistal portion of the shaft 16 (or two lumens therein) such that thedistal portions 58A, 58B of the rods 54A, 54B extend into the distaltube 14. More specifically, the distal portion 58A of rod 54A isdisposed in the wall 56 of the distal tube 14 at a position that is onthe opposite side of the wall 56 across the lumen 36 from the distalportion 58B. Further, as best shown in FIG. 7B, both distal portions58A, 58B (only 58B is visible in FIG. 7B because of the location ofdistal portion 58A behind distal portion 58B in the figure) extend at anangle toward a vertical midpoint of the tube 14 and extend horizontallyalong that position for some distance as well as shown. In accordancewith one implementation, the positioning of the distal portions 58A, 58Bof the rods 54A, 54B in the wall 56 of the distal tube 14 enhances thekink resistance of that portion of the tube 14 as well as assisting intransmitting a distal or proximal force to the distal tube 14 in a moreeven fashion during use of the catheter 10.

Additional embodiments of manipulation shafts 16 coupled to distal tubes14 are shown in FIGS. 8A-10. The device 10 depicted in FIGS. 8A and 8Bhas a manipulation shaft 16 coupled to the distal tube 14 such that adistal portion of the manipulation shaft 16 is positioned within thelumen 36 of the tube 14 or integrated into an outer wall 56 in thetransition zone 40 of the tube 14. In this embodiment, the taperedportion 47 of the shaft 16 is a taper along one side of the shaft 16such that the tapered portion 47 is an angled portion 47 on the side ofthe shaft 16 opposite the lumen 36 of tube 14. Hence, the opening 50 (oropenings in those embodiments in which the shaft 16 has two or morelumens) at the distal end of the shaft 16 is along the tapered portion47 of the distal end of the shaft 16 such that the opening 50 faces awayfrom the lumen 36 of the tube 14. In this specific embodiment as bestshown in FIG. 8B, the opening 50 is actually made up of multipleopenings 50 defined along the tapered portion 47 of the shaft 16 andouter wall 56 of the distal tube in fluid communication with the lumen38. Alternatively, the opening 50 can be a single opening, two openings,or any number of openings. In further alternatives in which the shaft 16has two or more lumens, each opening may be in fluid communication witha different lumen of the shaft 16, or each lumen may be in fluidcommunication with two or more separate openings that are not in fluidcommunication with any other lumens. In this exemplary implementation,the lumen 38—via the openings 50 in the shaft 16 and wall 56—is in fluidcommunication with an area or space outside the distal tube 14.Alternatively, the openings 50 can be on the side of the shaft 16 facingthe lumen 36 of tube 14 such that the lumen 38 is in fluid communicationwith the lumen 36 of tube 14. In a further embodiment, the shaft 16 hasno opening at the distal end of the shaft 16 and thus, while the distalend of the shaft 16 is positioned within the distal tube 14 or someportion thereof, the lumen 38 is not in fluid communication with thedistal tube 14 or any portion thereof. Alternatively, any embodimenthaving at least two lumens can have similar configurations (openings influid communication with an external area, openings in fluidcommunication with the lumen 36, or no openings).

The device 10 shown in FIG. 9 has a manipulation shaft 16 coupled to thedistal tube 14 such that a distal portion of the manipulation shaft 16is positioned within the lumen 36 of the tube 14 or integrated into anouter wall 56 in the transition zone 40 of the tube 14. In thisembodiment, the transition section 52 from the full diameter section 46to the reduced diameter section 48 of the shaft 16 is a taper around theentire circumference of the shaft 16 as shown. In this embodiment, thetransition section 52 is positioned outside the lumen 36 (or the outerwall 56) of the distal tube 14, and the opening 50 (or, alternatively,at least two openings in those embodiments having at least two lumens)at the distal end of the shaft is positioned within the lumen 36. Inthis exemplary implementation, the opening 50 is in direct fluidcommunication with the lumen 36 of tube 14 or is integrated into theouter wall 56 and is in fluid communication with the lumen 36 via anopening in the wall 56 of the tube 14. Any implementation having atleast two lumens can have any of these configurations as well.

The device 10 shown in FIG. 10 has a manipulation shaft 16 coupled tothe distal tube 14 such that a distal portion of the manipulation shaft16 is positioned within the lumen 36 of the tube 14 or integrated intoan outer wall 56 in the transition zone 40 of the tube 14. In thisembodiment, the transition section 52 of the shaft 16 is a taper 52around the entire circumference of the shaft 16 as shown. In thisembodiment, the transition section 52 is positioned within the lumen 36(or the outer wall 56) of the distal tube 14 such that the entirereduced diameter section 48 is positioned within the lumen 36 (or theouter wall 56). In this exemplary implementation, the opening 50 (or atleast two openings in those embodiments having at least two lumens) isin direct fluid communication with the lumen 36 of tube 14 or isintegrated into the outer wall 56 and is in fluid communication with thelumen 36 via an opening in the wall 56 of the tube 14. Alternatively,the lumen 38 (or at least two lumens) of the shaft 16 is not in fluidcommunication with the lumen 36 of tube 14.

It is understood that the manipulation shaft 16 in these embodiments ofFIGS. 8-10 can have a single lumen 38. Alternatively, the shaft 16 ofany of the three embodiments can have a lumen 38 containing one or twoelongate members in a fashion similar to the shaft 16 described abovewith respect to FIGS. 7A-7C. In a further alternative, the shaft 16 ofany embodiment disclosed or contemplated herein can have at least twolumens dispose therethrough, with certain of those implementationshaving one or more elongate members disposed through one or more of thelumens in a fashion similar to any of the embodiments herein havingelongate members. In another alternative, the shaft 16 can be configuredin any fashion as described elsewhere herein.

For example, as discussed above, certain implementations of the proximalshaft 16 have a tube defining two (or more) lumens in which two or moreseparate inner elongate members are positioned therethrough, with eachelongate member positioned through a different one of the lumens. In onespecific exemplary embodiment as best shown in FIG. 23, the manipulationshaft 16 is a tubular body 160 defining a first lumen 162A and a secondlumen 162B with two inner elongate members 164A, 164B positionedtherein, with the first elongate member 164A positioned in the firstlumen 162A and the second elongate member 164B positioned in the secondlumen 162B. In accordance with one implementation, the elongate members164A, 164B are fixedly attached to the tubular body 160 such that theelongate members 164A, 164B are not slidable in relation to the tubularbody 160. Alternatively, the members 164A, 164B are not fixedly attachedand are slidable in relation to the body 160. It is understood that theelongate members 164A, 164B can serve any purpose and be disposed withinor coupled to the distal member 14 according to any embodiment disclosedor contemplated herein. That is, according to certain exemplaryimplementations, the elongate members 164A, 164B extend from themanipulation shaft 16 into the distal tube or a wall or other portionthereof in a manner similar to the elongate members 54A, 54B depicted inFIGS. 7A-7C and discussed above or in any other manner as disclosed orcontemplated herein. Further, it is understood that the shaft 16depicted in FIG. 23 can alternatively have three or more lumens, withone or more additional elongate members disposed within any of thoseadditional lumens. The three or more lumens can also provide additionalflexibility (with each additional lumen adding additional flexibility)or can allow for fluid passage therethrough, as also described infurther detail elsewhere herein. In addition, the shaft 16 of FIG. 23can have a reduced diameter portion or any other manipulation shaftconfiguration according to any of the other implementations disclosed orcontemplated herein.

The elongate members 164A, 164B, according to one embodiment, havediameters that are substantially similar to or slightly less than theinner diameters of the lumens 162A, 162B such that the elongate members164A, 164B are disposed within the lumens 162A, 162B, respectively, andin contact with a substantially portion of the inner walls of thoselumens 162A, 162B. Alternatively, each elongate member 164A, 164B canhave any diameter that is less than the inner diameter of the lumens162A, 162B. In certain implementations, the elongate members 164A, 164Bhave diameters that are less than the inner diameters of the lumens162A, 162B such that a sufficient space is defined between the outersurfaces of the elongate members 164A, 164B and the inner surfaces ofthe lumens 162A, 162B such that fluid can be introduced through thelumens 162A, 162B. That is, in a fashion similar to other manipulationshaft 16 embodiments as described herein, fluids can be dispersedthrough the shaft 16, including fluids such as contrast solution, salinesolution, or therapeutic solutions, via one or both of the lumens 162A,162B. For example, either or both of the lumens 162A, 162B can beconfigured and the elongate members 164A, 164B can be sized to allow forfluids to pass through the space defined between the elongate members164A, 164B and the inner walls of the lumens 162A, 162B and be dispersedout of the distal end of the shaft 16. Further, the space between theouter surface of the elongate member (such as member 164A and/or member164B) and the inner surface of the lumen (such as lumen 162A and/orlumen 162B) can also provide additional flexibility (with eachadditional lumen having such space adding additional flexibility).

In certain implementations, the two or more lumens defined in thetubular body of the proximal shaft 16 can allow for the use of elongatemembers (such as members 164A, 164B) with smaller diameters than themembers used in shaft 16 embodiments having only one large lumen.Further, the proximal shaft 16 embodiments with two or more lumens (suchas lumens 162A, 162B, for example) and elongate members disposed thereinhave greater flexibility in comparison to proximal shaft 16 embodimentswith a single shaft and correspondingly larger elongate members.

The device 10 shown in FIG. 11 has a manipulation shaft 16 coupled tothe distal tube 14 such that a distal portion of the manipulation shaft16 is positioned within the lumen 36 of the tube 14 or integrated intoan outer wall 56 in the transition zone 40 of the tube 14. In thisembodiment, the reinforcing coil 62 of the tube 14 extends proximallyinto the transition zone 40 and has a larger pitch in the transitionzone 40. That is, the separate strands of the coil 62 are farther apartin the transition zone 40. According to one embodiment, this largerpitch results in lesser reinforcement or support by the coil 62 in thatarea of the tube 14. In certain embodiments, this is because the distalportion of the shaft 16 in the transition zone 40 provides additionalsupport or reinforcement.

The device 10 shown in FIG. 12 has a manipulation shaft 16 coupled tothe distal tube 14 such that a distal portion of the manipulation shaft16 is positioned within the lumen 36 of the tube 14 or integrated intoan outer wall 56 in the transition zone 40 of the tube 14. In thisembodiment, the distal portion of the shaft 16 has no tapered portionand extends along the entire length of the distal tube 14 such that theopening 50 (or openings) of the shaft 16 is positioned at the opening inthe distal end 42 of the tube 14. Alternatively, the shaft 16 can extenddistally out of the opening at the distal end 42 of the tube 14.

As discussed above, certain implementations of the proximal shaft 16have a tube or shaft body defining at least one lumen in which twoseparate inner elongate members are positioned. For example, themanipulation shaft 16 shown in FIG. 13 has an outer tube 80 defining alumen 82 with two inner elongate members 84A, 84B positioned therein.Alternatively, the shaft can have two lumens with each elongate memberdisposed in a separate lumen. The shaft 16 has a reduced diameterportion 48 in which both of the elongate members 84A, 84B have reduceddiameter portions 86A, 86B as shown. In this exemplary embodiment, eachelongate member 84A, 84B has a transition section 52A, 52B between thefull diameter section 46A, 46B and the reduced diameter section 48A, 48Bthat involves a narrowing around the full circumference of the members84A, 84B as shown.

Alternatively, the manipulation shaft 16 shown in FIG. 14 has an outertube 80 defining a lumen 82 with two inner elongate members 84A, 84Bpositioned therein. Alternatively, the tube 80 can have two lumens witheach elongate member 84A, 84B disposed in separate lumens. The shaft 16has a tapered section 47 in which both of the elongate members 84A, 84Bhave tapered sections 47A, 47B as shown. In this exemplary embodiment,each elongate member 84A, 84B has an extended taper from the fulldiameter section 46A, 46B to the reduced diameter section 48A, 48B.

As mentioned above with respect to certain specific embodiments, thecross-sectional configuration of the manipulation shaft 16 can take anynumber of different forms. For example, FIGS. 15A and 15B depictcross-sectional configurations of different manipulation shaft 16embodiments. FIG. 15A depicts a shaft 16 comprised of an elongate member16 having a metal body 100 with a square or parallelogram-shapedcross-section and a polymeric outer coating 80. The metal body 100defines a lumen 102 in the body 100 that runs along the entire length ofthe body 100.

In an alternative configuration as shown in FIG. 15B, the shaft 16 hasan elongate member 16 with a metal body 100 having a square orparallelogram-shaped cross-section and a polymeric outer coating 80. Inaddition, the metal body 100 defines a lumen 102 in the body 100 thatruns along the entire length of the body 100. Further, a tube 104 isprovided that is positioned within the lumen 102 in the body 100. Thetube 104 can be made of metal or a polymeric material. In a furtherembodiment, the tube 104 is a polymeric coating 104 that is configuredto line the lumen 102.

FIG. 16A depicts the cross-section of the manipulation shaft 16according to another embodiment in which the shaft 16 is a hollow tube16 with a circular cross-section. FIG. 16B depicts a shaft 16 that is ahollow tube 16 with a relatively square cross-section. FIG. 16C shows ashaft 16 that is a hollow tube 16 with a relatively rectangularcross-section. FIG. 16D depicts a shaft 16 that is a hollow tube with arelatively ovular cross-section. FIG. 16E shows a shaft 16 that is ahollow tube 16 with a relatively kidney bean-shaped cross-section. Theshaft 16 in FIG. 16F is an elongate member 16 with a lumen 82 in whichtwo smaller, hollow elongate members 84A, 84B are disposed. FIG. 16Gdepicts an elongate member 16 with a lumen 82 in which two smaller,solid (non-hollow) elongate members 84A, 84B are disposed. FIG. 16Hshows an elongate member 16 having a substantially ovular cross-sectionwith a lumen 82 in which a single smaller elongate member 84 isdisposed. FIG. 161 depicts an elongate member 16 with a lumen 82 inwhich two smaller, solid (non-hollow) elongate members 84A, 84B and athird smaller hollow elongate member 84C are disposed.

With respect to the shafts 16 shown in FIGS. 16F, 16G, 16H, and 161, theadditional smaller elongate members 84A, 84B, 84C disposed within thelumen 82 of the shaft 16 add support or reinforcement to the shaft 16while also having multiple lumens within the shaft 16. For example, theshaft 16 in FIG. 16F has two lumens 88A, 88B in the two elongate members84A, 84B, along with two lumens 82A, 82B created in the spaces on eitherside of the two elongate members 84A, 84B. Similarly, it should be notedthat the shaft 16 configurations described above and depicted in FIGS.7A-7C, 13, and 14 have similar configurations that also have lumens inthe spaces created by the elongate members disposed therein. The shaft16 in FIG. 16G has two lumens 82A, 82B created in the spaces on eitherside of the two solid (non-hollow) elongate members 84A, 84B. In FIG.16H, the shaft 16 has a single larger lumen 82 defined by the shaft 16with the single elongate member 84 disposed therein. In FIG. 161, theshaft 16 has a lumen 88 within the hollow elongate member 84C and twolumens 82A, 82B in the spaces on either side of the member 84C. Inaddition, another cross-sectional profile of a manipulation shaft 16 isdepicted in FIG. 23, as discussed above. In that implementation, thebody 160 has two lumens 162A, 162B defined within the body 160 with thefirst elongate member 164A disposed in the first lumen 162A and thesecond elongate member 164B disposed in the second lumen 162B. Further,it is understood that any of these configurations as shown in FIGS.16A-16I and 23 can be any combination or number of solid and/or hollowelongate members.

In a further implementation as shown in FIG. 24, the manipulation shaft16 has a body 170 with three lumens 172A, 172B, 174 defined therein. Inthis embodiment, two of the lumens 172A, 172B are sized to receiveelongate members such that a first elongate member 176A is disposed inthe first lumen 172A and a second elongate member 176B is disposed inthe second lumen 172B. In accordance with one implementation, theelongate members 176A, 176B are fixedly attached to the tubular body 170such that the elongate members 176A, 176B are not slidable in relationto the tubular body 170. Alternatively, the members 176A, 176B are notfixedly attached and are slidable in relation to the body 170. Further,the third lumen 174 provides additional flexibility to the body 170 suchthat the body 170 is more flexible along the length of the body 170 as aresult of the third lumen 174. Alternatively, the third lumen 174 canallow for passage of fluids of any kind (such as procedural fluids, forexample) through the manipulation shaft 16 according to any of theembodiments relating to passage of fluids through the manipulation shaft16 as described in additional detail elsewhere herein. In a furtheralternative, the body 170 can have at least two additional lumens (inaddition to the elongate member lumens 172A, 172B discussed above). Inyet another alternative, the body 170 can have any number of elongatemember lumens and additional lumens.

It is understood that the elongate members 176A, 176B can serve anypurpose and be disposed within or coupled to the distal member 14according to any embodiment disclosed or contemplated herein. That is,according to certain exemplary implementations, the elongate members176A, 176B extend from the manipulation shaft 16 into the distal tube ora wall or other portion thereof in a manner similar to the elongatemembers 54A, 54B depicted in FIGS. 7A-7C and discussed above or in anyother manner as disclosed or contemplated herein.

The elongate members 176A, 176B, according to one embodiment, havediameters that are substantially similar to or slightly less than theinner diameters of the lumens 172A, 172B such that the elongate members176A, 176B are disposed within the lumens 172A, 172B, respectively, andin contact with a substantially portion of the inner walls of thoselumens 172A, 172B. Alternatively, each elongate member 176A, 176B canhave any diameter that is less than the inner diameter of the lumens172A, 172B.

In certain implementations, the three or more lumens defined in thetubular body of the proximal shaft 16 in FIG. 24 can allow for the useof elongate members (such as members 176A, 176B) with smaller diametersthan the members used in shaft 16 embodiments having only one largelumen. The use of smaller elongate members can result in additionalflexibility in comparison to embodiments having larger elongate members.As such, the proximal shaft 16 embodiments with three or more lumens(such as elongate member lumens 172A, 172B, plus the third lumen 174,for example) and elongate members disposed within the appropriate lumenshave greater flexibility in comparison to proximal shaft 16 embodimentswith a single shaft and correspondingly larger elongate members.

In some embodiments, the elongate members 84A, 84B, 84C, 164A, 164B,176A, 176B are slideably disposed within the shaft 16, such that theelongate members 84A, 84B, 84C, 164A, 164B, 176A, 176B are slideable inrelation to the shaft 16 and each other. Alternatively, the elongatemembers 84A, 84B, 84C are joined, bonded, or otherwise coupled to eachother such that they are not slidable in relation to each other. In afurther implementation, the elongate members 84A, 84B, 84C can becoupled or otherwise joined to each other and to the shaft 16 such thatthey are not slideable in relation to each other or the shaft 16.Further, the elongate members 164A, 164B, 176A, 176B can be coupled orotherwise joined to the respective body 160, 170 such that they are notslideable in relation to each other or the body 160, 170.

According to various embodiments, the manipulation shaft 16 can have adiameter that ranges from about 0.01 inches to about 0.03 inches (or canhave a size that ranges from about ¼ French to about 3 French). Thevarious inner elongate members can be made of stainless steel, nitinol,or other similar metals. In those embodiments with inner elongatemembers, the outer wall of the shaft 16 is made of polymeric materialssuch as PET, PTFE, Teflon, FEP, PE, PEBA, or other similar materials.

As shown in FIGS. 2B and 17A, the manipulation shaft 16 can terminate ina proximal fitting 32. In accordance with one embodiment, the fitting 32is adapted for connection to a fluid source. In certain embodiments, thefitting 32 is a standard female luer connection that is made fromplastic. The fitting 32 can be bonded to the manipulation shaft 16 withadhesive, or it can be insert-molded over the manipulation shaft 16. Inthe embodiment shown in FIG. 17A, there is an optional strain-reliefsegment 34 disposed between the manipulation shaft 16 and the proximalfitting 32. The strain relief segment 34 provides a flexible transitionfrom the manipulation shaft 16 to the proximal fitting 32.

Alternatively, in FIG. 17B, the proximal end of the lumen 38 in theshaft 16 does not have an opening. That is, the proximal end of thelumen 38 (or at least two lumens) is not in fluid communication with anyopening at the proximal end of the shaft 16.

Other device 10 embodiments include additional support structure in thedistal tube 14 that can provide mechanical advantage similar to thatprovided by the support coil. FIG. 18A depicts a device 10 having adistal tube 14 with a support member 110 positioned in the transitionzone 40 that is configured to assume at least some of the mechanicalloads. Alternatively, FIG. 18B depicts another embodiment of a supportmember 110 positioned in the transition zone 40 of a distal tube 14,while FIG. 18C shows a further implementation of a support member 110.In a further alternative, the tube 14 can have two or more supportmembers. In certain embodiments, the support member (including thesupport members 110 depicted in FIGS. 18A-18C) can be the distal portionof the rod or tube extending distally from the shaft 16.

In use, the device 10 according to any of the embodiments disclosedherein can be used to conduct a predetermined amount of contrastsolution (or any other fluid that could be used in this context asdescribed above) from a reservoir in an operating room into a human bodyto a predetermined location. In one embodiment, the method can involvethe steps of: introducing a guiding catheter into a human body along apredetermined pathway to a predetermined location; inserting theboosting catheter 10 into the guiding catheter, where the boostingcatheter 10 includes the proximal portion 16 and the distal portion 14,and moving it distally along the guiding catheter a predetermineddistance; introducing the solution into the proximal end of the proximalportion through the one or more lumens therein; conducting the fluidalong the length of the proximal portion 16 through the lumen(s); anddispersing the solution distal of the proximal portion 16 into the humanbody in order to make the portion of the body (typically an artery orvein) visible to a doctor using an x-ray or similar device. It isfurther understood that any of the device implementations disclosed orcontemplated herein can be used to perform any of the proceduresdescribed above with respect to FIG. 1.

Alternative manipulation shaft 16 embodiments are shown in FIGS.19A-19D″. These various shaft 16 embodiments have various openingconfigurations, including gradual tapered sections or tapered sections,including some such sections at the distal opening, at the distal end ofthe shaft 16. In certain implementations, the tapered section can becreated via cutting or grinding processes. Alternatively, any knownprocess for creating such a tapered configuration can be used.

FIGS. 19A and 19A′ show a shaft 16 having a a shallow tapered section 47and a straight extension 120. FIG. 19B depicts a shaft 16 having atapered section 47 without a straight extension. FIG. 19C shows a shaft16 with a curved tapered section 47. FIG. 19D shows a shaft 16 with adistal end that is perpendicular to the longitudinal axis of the shaft16, and a short segment of flat wire 122 can be coupled to it, such asin a slot joint 124 (FIG. 6D′) or a lap joint 126 (FIG. 6D″).

As shown in FIG. 20A, the proximal end 44 of the distal tube 14 may beconfigured so that the opening 130 is perpendicular to the axis of thetube 14. In other embodiments, the opening 130 can be tapered, as shownin FIG. 20B; or the opening 130 may be flared, as shown in FIG. 7C.Still further, the opening 130 may be extended with an axially-extendingslit 30 in the wall of the tube, as shown in FIG. 20A. In these latterthree embodiments, the purpose of the enlarged opening 130 (and the slit30) is to facilitate movement of tools and medical devices along theaxis of the boosting guide catheter.

In a further implementation as shown in FIG. 20D, the proximal end ofthe distal tube 14 has one or more holes 132, slots, or any kind ofopenings defined in the wall of the tube 14. In the specific exampledepicted, the tube 14 has three slots 132, each of which has a long sidethat is perpendicular with the longitudinal axis of the tube 14.Alternatively, the tube 14 can have less than three or more than threeholes. In accordance with certain embodiments, the one or more openings132 can act as hinge-like components that allows for flexure of theproximal end of the tube 14 while minimizing or preventing bucklingthereof.

According to a further embodiment depicted in FIGS. 21A and 21B, thedevice 140 has a manipulation shaft 16 that is made up of two rods 54A,54B positioned within the lumen 38 of the shaft 16 (as best shown inFIG. 21B). Alternatively, the two rods 54A, 54B can be positioned withinseparate lumens in the shaft 16. FIG. 21A is a side view, while FIG. 21Bis a top view. In this implementation, the shaft 16 is a polymericcoating 16 such as polyester and/or PET. A distal portion of the shaft16 is coupled to and integral with an outer wall 56 of the distal tube14 at the transition zone 40. Further, the two rods 54A, 54B extend fromthe distal portion of the shaft 16 such that the distal portions 58A,58B of the rods 54A, 54B extend into the distal tube 14. Morespecifically, the distal portion 58A of rod 54A is disposed in the wall56 of the distal tube 14 at a position that is on the opposite side ofthe wall 56 across the lumen 36 from the distal portion 58B. Further, asbest shown in FIG. 21A, both distal portions 58A, 58B (only 58B isvisible in FIG. 21A because of the location of distal portion 58A behinddistal portion 58B in the figure) extend at an angle toward a verticalmidpoint of the tube 14 and extend horizontally along that position forsome distance as well as shown. In this specific implementation, both ofthe distal portions 58A, 58B of the rods 54A, 54B have a flatconfiguration, thereby reducing their profiles within the distal tube14. In addition, in this implementation, a tube 142 is positionedbetween the two rods 54A, 54B, with the proximal end of the tube 142extending into the shaft 16 and the distal end extending into the distaltube 14 as shown. According to certain embodiments, the tube 142 ispositioned in a third lumen defined in the shaft 16. It is understoodthat the proximal end of the tube 142 can be positioned at any pointalong the length of the manipulation shaft 16. Alternatively, theproximal end of the tube 142 can extend to the proximal end of themanipulation shaft 16. According to one embodiment, the tube 142 has alumen (not shown) in fluid communication with the lumen 38 (or a thirdlumen defined within the shaft 16 as described above) of themanipulation shaft 16 and further in fluid communication with the lumen36 of the distal tube. Alternatively, the tube 142 can have a lumen (notshown) that is not in fluid communication with the lumen 38 or the lumen36. In yet another alternative, the tube 142 has no lumen. Further, inthis embodiment, two marker bands 144 are positioned around the rods54A, 54B.

FIGS. 22A, 22B, and 22C depict another device 150 having a manipulationshaft 16 that is made up of two rods 54A, 54B positioned within thelumen 38 (or two separate lumens as discussed above) of the shaft 16.FIG. 22A is a side view, while FIG. 22B is a top view and FIG. 22C is anunderside view. As in the embodiment shown in FIGS. 21A and 21B, the tworods 54A, 54B extend into the distal tube 14. Further, the two distalportions 58A, 58B have a flat configuration as shown. The distal portion58A is disposed in the wall 56 of the distal tube 14 at a position thatis on the opposite side of the wall 56 across the lumen 36 from thedistal portion 58B. Further, as best shown in FIG. 22A, both distalportions 58A, 58B (only 58B is visible in FIG. 22A because of thelocation of distal portion 58A behind distal portion 58B in the figure)extend at an angle toward a vertical midpoint of the tube 14 and extendhorizontally along that position for some distance as well as shown.Unlike the prior embodiment (in FIGS. 21A and B), this implementationhas no additional tube disposed between the two rods 58A, 58B.

What is claimed is:
 1. A catheter comprising: (a) a distal tubecomprising a tubular wall, a tube lumen defined within the tube by thetubular wall, and a proximal opening in fluid communication with thetube lumen, wherein the proximal opening is configured to allow amedical device to be positioned therethrough; and (b) a proximal shaftoperably coupled to a proximal portion of the distal tube, the proximalshaft comprising: (i) a first shaft lumen defined in the proximal shaft;(ii) a second shaft lumen defined in the proximal shaft; (iii) a firstelongate member disposed within the first shaft lumen; and (iv) a secondelongate member disposed within the second shaft lumen, wherein theproximal shaft is configured to extend distally into a portion of thedistal tube such that the shaft lumen extends distally past a proximalend of the distal tube.
 2. The catheter of claim 1, wherein the firstelongate member is configured to extend distally into a first portion ofthe tubular wall, and the second elongate member is configured to extenddistally into a second portion of the tubular wall.
 3. The catheter ofclaim 1, wherein the proximal shaft further comprises a first distalopening in fluid communication with the first shaft lumen and a seconddistal opening in fluid communication with the second shaft lumen,whereby the first and second shaft lumens are in fluid communicationwith the tube lumen.
 4. The catheter of claim 3, wherein at least oneof: the first shaft lumen is configured to receive fluid such that fluidcan be caused to flow distally in a space defined between an inner wallof the first shaft lumen and the first elongate member and out of thefirst distal opening, and the second shaft lumen is configured toreceive fluid such that fluid can be caused to flow distally in a spacedefined between an inner wall of the second shaft lumen and the secondelongate member and out of the second distal opening.
 5. The catheter ofclaim 3, wherein the proximal shaft is configured to extend distallyinto a portion of the tubular wall such that the first and second shaftlumens extend distally into the tubular wall and such that the first andsecond distal openings are in fluid communication with the tube lumen.6. The catheter of claim 1, wherein the first elongate member is fixedlydisposed within the first shaft lumen, such that the first elongatemember is not slidable in relation to the first shaft lumen, and thesecond elongate member is fixedly disposed within the second shaftlumen, such that the second elongate member is not slidable in relationto the second shaft lumen.
 7. The catheter of claim 1, wherein the firstelongate member is slidably disposed within the first shaft lumen suchthat the first elongate member is slidable in relation to the firstshaft lumen, and the second elongate member is slidably disposed withinthe second shaft lumen such that the second elongate member is slidablein relation to the second shaft lumen.
 8. The catheter of claim 1,wherein at least one of the first and second elongate members defines alumen therein.
 9. The catheter of claim 1, wherein the first and secondelongate members have no lumen.
 10. The catheter of claim 1, wherein theproximal shaft further comprises a third shaft lumen defined in theproximal shaft and a third distal opening in fluid communication withthe third shaft lumen, whereby the third shaft lumen is in fluidcommunication with the tube lumen.
 11. The catheter of claim 10, whereinthe third shaft lumen is configured to receive fluid such that fluid canbe caused to flow distally along the third shaft lumen and out of thethird distal opening.
 12. The catheter of claim 10, wherein the proximalshaft further comprises at least a fourth shaft lumen defined in theproximal shaft and at least a fourth distal opening in fluidcommunication with the at least the fourth shaft lumen, whereby the atleast the fourth shaft lumen is in fluid communication with the tubelumen.
 13. A method of using a boosting catheter in combination with astandard guiding catheter to perform a procedure at a predeterminedlocation within the vasculature of a patient, the method comprising:positioning the standard guiding catheter into a target vessel in thepatient; inserting the boosting catheter into the standard guidingcatheter, the boosting catheter comprising: (a) a distal tube comprisinga tubular wall and a tube lumen defined within the tube by the tubularwall; and (b) a proximal shaft operably coupled to a proximal portion ofthe distal tube, the proximal shaft comprising: (i) first and secondshaft lumens defined in the proximal shaft; and (ii) first and secondelongate members disposed in the first and second shaft lumens,respectively, wherein each of the first and second elongate members isconfigured to extend distally into a portion of the tube lumen; urgingthe boosting catheter distally through the standard guiding cathetersuch that a distal portion of the distal tube extends distally out ofthe distal end of the standard guiding catheter; and performing aprocedure through the boosting catheter and standard guiding catheter.14. The method of claim 13, wherein the proximal shaft further comprises(a) a first distal opening in fluid communication with the first shaftlumen, whereby the first shaft lumen is in fluid communication with thetube lumen; and (b) a second distal opening in fluid communication withthe second shaft lumen, whereby the second shaft lumen is in fluidcommunication with the tube lumen.
 15. The method of claim 14, whereinthe performing the procedure further comprises: introducing the fluidinto at least one of the first and second shaft lumens at the proximalend of the proximal shaft; and conducting the fluid distally along thelength of the at least one of the first and second shaft lumens and outof at least one of the first and second distal openings.
 16. The methodof claim 13, wherein the performing the procedure further comprises:positioning a medical device at the predetermined location through theboosting catheter and guiding catheter; and performing aninterventional, diagnostic, or therapeutic procedure using the medicaldevice.
 17. The method of claim 13, wherein the proximal shaft furthercomprises a third shaft lumen defined in the proximal shaft and a thirddistal opening in fluid communication with the third shaft lumen,whereby the third shaft lumen is in fluid communication with the tubelumen.
 18. The method of claim 17, wherein the performing the procedurefurther comprises: introducing a fluid into the third shaft lumen at aproximal end of the proximal shaft; and conducting the fluid distallyalong the length of the third shaft lumen and out of the third distalopening.
 19. The method of claim 18, wherein the conducting the fluidout of the third distal opening further comprises conducting the fluidout of the third distal opening into the lumen of the distal tube. 20.The method of claim 18, wherein the conducting the fluid out of thethird distal opening further comprises dispersing the fluid out of thethird distal opening to an area external to the distal tube.
 21. Themethod of claim 17, wherein the proximal shaft further comprises atleast a fourth shaft lumen defined in the proximal shaft and at least afourth distal opening in fluid communication with the at least thefourth shaft lumen, whereby the at least the fourth shaft lumen is influid communication with the tube lumen.
 22. The method of claim 13,wherein the first elongate member is fixedly disposed within the firstshaft lumen, such that the first elongate member is not slidable inrelation to the first shaft lumen, and the second elongate member isfixedly disposed within the second shaft lumen, such that the secondelongate member is not slidable in relation to the second shaft lumen.23. The method of claim 13, wherein the first elongate member isslidably disposed within the first shaft lumen such that the firstelongate member is slidable in relation to the first shaft lumen, andthe second elongate member is slidably disposed within the second shaftlumen such that the second elongate member is slidable in relation tothe second shaft lumen.
 24. A method of using a boosting catheter incombination with a standard guiding catheter to perform a procedure at apredetermined location within the vasculature of a patient, the methodcomprising: positioning the standard guiding catheter into a targetvessel in the patient; inserting the boosting catheter into the standardguiding catheter, the boosting catheter comprising: (a) a distal tubecomprising a tubular wall, a tube lumen defined within the tube by thetubular wall, and a proximal opening in fluid communication with thetube lumen, wherein the proximal opening is sized to allow a medicaldevice to be positioned therethrough; and (b) a proximal shaft operablycoupled to a proximal portion of the distal tube, the proximal shaftcomprising: (i) first and second shaft lumens defined in the proximalshaft; (ii) a first elongate member disposed within the first shaftlumen, the first elongate member configured to extend distally into afirst portion of the tubular wall; and (iii) a second elongate memberdisposed within the second shaft lumen, the second elongate memberconfigured to extend distally into a second portion of the tubular wall;urging the boosting catheter distally through the standard guidingcatheter such that a distal portion of the distal tube extends distallyout of the distal end of the standard guiding catheter; and performing aprocedure using the medical device.
 25. The method of claim 24, whereinthe proximal shaft further comprises first and second distal openings influid communication with the first and second shaft lumens,respectively, wherein the performing the procedure further comprises:introducing a fluid into the first and second shaft lumens at a proximalend of the proximal shaft; and conducting the fluid distally along thelength of the first and second shaft lumens and out of the distalopening.
 26. The method of claim 25, wherein the first and second shaftlumens are in fluid communication with the tube lumen, wherein theconducting the fluid out of the first and second distal openings furthercomprises conducting the fluid out of the first and second distalopenings into the tube lumen of the distal tube.
 27. The method of claim25, wherein the first and second shaft lumens are in fluid communicationwith an area external to the distal tube, wherein the conducting thefluid out of the first and second distal openings further comprisesconducting the fluid out of the first and second distal openings intothe area external to the distal tube.